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Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study
Xue WY, Li X, Li WT, Qin BZ, Wang CZ, Liu T, Wang M.. Therapeutic advances in drug safety, 2026-08-18
Topic: Brain proteins, microglia and lab models
Objectives To compare post-marketing adverse event profiles of lecanemab (LEC) and donanemab (DON), identify report-level factors associated with ARIA-E, and develop a machine learning model for ARIA-E risk stratification. Multivariable logistic regression was used to examine factors associated with report-level ARIA-E. Results FAERS included 2961 lecanemab and 1542 donanemab primary suspect reports; WHO-VigiAccess included 2525 lecanemab- and 1450 donanemab-related reports. In complete-case regression, no overall difference in ARIA-E reporting odds was observed between donanemab and lecanemab, whereas a significant donanemab-by-body weight interaction was identified.
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APA 7th
Xue, W. Y., Li, X., Li, W. T., Qin, B. Z., Wang, C. Z., Liu, T., et al. (2026). Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study. Therapeutic advances in drug safety. https://doi.org/10.1177/20420986261473013
Vancouver
Xue WY, Li X, Li WT, Qin BZ, Wang CZ, Liu T, et al. Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study. Therapeutic advances in drug safety. 2026. doi:10.1177/20420986261473013. PMID: 42621237.
BibTeX
@article{xue2026-42621237,
author = {Xue, W. Y. and Li, X. and Li, W. T. and Qin, B. Z. and Wang, C. Z. and Liu, T. and Wang, M.},
title = {{Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study}},
journal = {Therapeutic advances in drug safety},
year = {2026},
doi = {10.1177/20420986261473013},
pmid = {42621237},
url = {https://doi.org/10.1177/20420986261473013}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
Key findings
- Objectives To compare post-marketing adverse event profiles of lecanemab (LEC) and donanemab (DON), identify report-level factors associated with ARIA-E, and develop a machine learning model for ARIA-E risk stratification.
- Multivariable logistic regression was used to examine factors associated with report-level ARIA-E.
- Results FAERS included 2961 lecanemab and 1542 donanemab primary suspect reports; WHO-VigiAccess included 2525 lecanemab- and 1450 donanemab-related reports.
- In complete-case regression, no overall difference in ARIA-E reporting odds was observed between donanemab and lecanemab, whereas a significant donanemab-by-body weight interaction was identified.
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Study details
- Participants2,961
- Evidence strengthLow
How this study scored 57/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 33 of the 58 points we could judge it on, which is 57 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Therapeutic advances in drug safety) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 3 / 4 | 2,961 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 42621237) |
| Free to read | 2 / 2 | Free to read |
| Points | 33 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 33 of the 58 points we could judge it on is 57 out of 100. |
| Total | 57 / 100 | — |
What each of these 20 components measures, and what this score is not →
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